Kornimate/medical-research-clean huggingface dataset:
remune hiv/aids vaccine phase ii pediatric safety & efficacy clinical study

Conditions: HIV/AIDS

Summary: the primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of hiv viral load \& increase changes in wbc white blood cell counts in the adult remune dose vs the low dose remune placebo groups. additional objectives include changes in cd4+ \& cd8+ t cell counts along with increased hiv immunity.

this is a 26 subject multi center double-blind randomized, safety \& efficacy, pediatric hiv/aids phase ii study, to primarily to evaluate the safety and efficacy of hiv-1 immunogen and secondarily to examine changes in cd4+ \& cd8+ t cell counts, determine remune vaccines effect of multiple inoculations of hiv-1 immunogen on viral replication in children with hiv-1 infection \& immunogenicity of remune. multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of remune.

Eligibility criteria:
inclusion criteria: * children clinically diagnosed with hiv that are 3 months of age to the age 16 years old * subjects on any approved fda antiviral medication except triple cocktail haart drugs exclusion criteria: * truvada * triple cocktail haart drugs * healthy subjects

Keywords: hiv/aids pediatric vaccine hiv-1 immunogen
a comparison of rate response performance in pacemaker patients with an indication of sinus node dysfunction

Conditions: Sinus Node Dysfunction

Summary: providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living. medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (adl) response rate and an "exertion" response rate. there is much data to support the target heart rate for an exercise response but the data to support the programming of the adl rate is lacking.

medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (adl) response rate and an "exertion" response rate. there is much data to support the target heart rate for an exercise response but the data to support the programming of the adl rate is lacking. unpublished holter data from our center indicates that the adl rate for most patients in our practice is between 50-70bpm rather than 95bpm. moreover, this increased adl rate may impact diastolic filling times and adversely impact cardiac output.

Eligibility criteria:
inclusion criteria: * diagnosis of hypertension * sinus node dysfunction * new implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or chronotropic incompetence defined as exercise heart rate less than 100 beats per minute exclusion criteria: * second or third degree av block * age less than 60 or greater than 95 years * ef less than 45% * patients that are not ambulatory * persistent atrial fibrillation (atrial fibrillation lasting greater than 7 days) * permanent atrial fibrillation (atrial fibrillation lasting great than 1 year)

Keywords: sinus node dysfunction
remote delivery of weight management for adults with idd

Conditions: Obesity

Summary: the purpose of this study is to compare different weight loss programs in people with idd to see which program works better.


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate idd as determined by a community service provider operating in kansas under the auspices of a community developmental disability organization (cddo). participants will be judged competent to provide informed consent by their cddo, or will have a guardian with power of attorney. * ability to provide assent, regardless of guardian consent. * bmi of 25 to 45 kg/m2 * sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language * living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner * no plans to relocate outside the study area over the next 24 months * internet access in the home exclusion criteria: * unable to participate in moderate-to-vigorous physical activity (mvpa) * insulin dependent diabetes * participation in a weight management program involving diet and physical activity in the past 6 months * serious food allergies, consuming special diets (vegetarian, atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of prader-willi syndrome * pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months. * serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty * unwilling to be randomized.

Keywords: weight loss weight management
breast feeding analgesia in preterm infants

Conditions: Pain

Summary: the purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure hypothesis: 1. when breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier. 2. following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.

research method: in a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. for the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. for the feeding condition, infants will be held and then breast fed by their mother during the blood collection.

Eligibility criteria:
inclusion criteria: * born between 30-36 weeks gestational age * breastfeeding * mother has fluent english exclusion criteria: * cns injury * congenital anomaly * active infection * has had surgeries or analgesics/sedatives in last 72 hours * history of maternal drug exposure

Keywords: pain response
urgent-sq in treatment of overactive bladder syndrome: 9-yr follow up

Conditions: Overactive Bladder; Urinary Frequency or Urgency Adverse Event; Urinary Incontinence, Urge

Summary: long term open label study on safety and durability of the urgent-sq tibial implant device for refractory overactive bladder syndrome (oab).

this is a follow-up study of the study by van der pal et al. (see reference). the urgent-sq is an ankle (tibail) implant that is used for on demand electical stimulation that stimulates the tibial nerve for the treatment of overactive bladder syndrome (oab). the implant is placed via an minimal invasive surgical procedure. the implant can be activated with an external pulse generator. this study by van de pal et al. was conducted with the approval of the local medical ethical committee and with a one year systematic follow-up of eight patients. since then, follow-up up and use of the device was open-label. this study reports on the long-term (9yrs) the safety and durability of the urgent-sq implant in these eight patients. parameters evaluated were local pain and discomford at the site of the implant, ae's related to the implant or the use of the implant. current use of the treatment and effectivity of the treatment. van der pal f, van balken mr, heesakkers jp, debruyne fm, bemelmans bl.implant-driven tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: 12-month follow-up. neuromodulation. 2006 apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.

Eligibility criteria:
inclusion criteria: * refractory overactive bladder syndrome that have an urgent-sq tibial nerve implant in 2003-2004 exclusion criteria: * patient who had the implant removed before the first year after implantation.

Keywords: oab overactive bladder urgency incontinence
wound healing process in diabetic neuropathy and diabetic neuroischemia

Conditions: Diabetes

Summary: diabetes mellitus is one of the leading causes of illness worldwide. diabetes can affect nerves, skin and blood vessels. diabetics with problems in their nerves can lose the sense of touch in their feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. diabetics also have difficulty healing any damaged tissues especially if the patients have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia).

diabetes mellitus is one of the leading causes of illness worldwide. diabetes can affect nerves, skin and blood vessels. diabetics with problems in the patients nerves can lose the sense of touch in the patient's feet (called neuropathy) and so may unknowingly cause damage to the skin resulting in skin loss or an 'ulcer'. diabetics also have difficulty healing any damaged tissues especially if the patient have diseased blood vessels causing a lack of blood to areas of the body including the feet (called ischaemia). therefore diabetics have a greater chance of having an ulcer and a higher chance that it does not heal up. the loss of a protective skin barrier means that bacteria can enter the foot causing infections which can spread to bone and beyond. ultimately this can result in gangrene, amputation or even death. stem or progenitor cells help repair and replace damage in the body. blood vessels are key to this repair. recent research has suggested that special progenitor cells found in the blood may be responsible. they are called endothelial progenitor cells (epcs) and seem to be in fewer numbers and are less effective at repair in diabetics. current treatments for diabetic wounds are not always successful and so the investigators need more research to look at new treatments. one possibility is to use electrical stimulation of nerves in the leg. research studies have shown this may improve blood circulation and healing of wounds. this research will assess epcs to see if they are linked to ulcer healing in diabetic patients with neuropathy only or with ischaemia as well. furthermore the investigators wish to investigate whether electrical stimulation can affect progenitor cells and wound healing in these patients. the longterm goal of this research is to help diabetic patients improve their quality of life by reducing wound related complications

Eligibility criteria:
inclusion criteria: * consenting patients with type 1 or 2 diabetes. * male or female, aged 18-85 years. * presence of significant neuropathic ulcers. * presence of significant neuroischaemic ulcers. * patients who are able and willing to follow the protocol requirements. exclusion criteria: * unreliable, unwilling or unable to comprehend informed consent. * patients with recently diagnosed or with suspected deep vein thrombosis (dvt). * patients without neuroischaemic/ neuropathic ulcers * patients with cardiac demand pacemakers. * patients who are pregnant.
bioequivalence study between "dong-a atorvastatin tab" and "lipitor tab"

Conditions: Healthy

Summary: an open-label, randomized, 2-sequence, 4-period, fasting condition, single-dose, per oral, cross-over study to evaluate the bioequivalence between "dong-a atorvastatin 80mg tab" and "lipitor 80mg tab" in healthy volunteers

1. study design: an open-label, randomized, 2-sequence, 4-period, fasting condition, single-dose, per oral, cross-over study 2. administration method: the subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (dong-a atorvastatin 80mg or lipitor 80mg) with 150 ml of water at around 8 a.m. on the day of the test. the subject should not chew or break the drug, but should swallow in whole with water. the difference in administration time between the test subjects is about one minute apart, considering the blood collection time. 3. wash out period: at least 7 days 4. blood collection time: before the administration, 0.17, 0.33, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12, 24, 36 hr after the administration (total 16 times) 5. analysis: measurement of the concentration of an unchangeable substance of atorvastatin in plasma

Eligibility criteria:
inclusion criteria: 1. a person who aged 19 or older at the time of screening 2. bmi of 18 to 30 (bmi calculation: kg/m2) * males weighing 50kg or more * females weighing 45kg or more 3. no congenital or chronic diseases or pathological symptoms 4. a person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination 5. a person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature 6. a person who agreed to use contraception from the first administration of ip to a week after the last administration of ip exclusion criteria: 1. a person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of ip 2. a person who has participated in other clinical trials within six months prior to the first administration of the ip 3. a person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before the first administration of ip 4. a person who has medical history of gastric resection that can affect the drug absorption 5. a person with a history of regular alcohol intake within a month prior to the first administration of the ip: * male: more than 21 cups/week * female: more than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits) 6. a person who is hypersensitive to any of the ip components, taking glecaprevir, pibrentasvir, has active hepatic disease, blood ast (got) or alt (gpt) levels exceed the upper reference range limit by 3 times, muscle disease, or any genetic symtoms such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 7. a person who has medical history of mental disease 8. a person who is judged not to be suitable for the study by the investigator 9. lactating or possibly pregnant women
electrostimulation of skeletal muscles in patients listed for a heart transplant

Conditions: Sarcopenia; Heart Failure, Systolic

Summary: heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. it is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. in patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. although exercise is recommended as a component of heart failure management, adherence is consistently low. this is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity. in this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.


Eligibility criteria:
inclusion criteria: * patients with end-stage heart disease, listed for heart transplantation * already received standard treatment based on patient condition * are receiving guideline recommended pharmacologic therapy * able to follow protocol procedures * assigned the informed consent * do not regularly exercise (10 minutes or more a day of exercise most days of the week for the past week). exclusion criteria: * unos 1a or 1b patients * already receive nmes at femoris area in last 6 weeks before admission * patients, who have undertaken cardiac rehab within the 12 months prior to enrollment * cognitive, orthopedic or neurological disorders or other impairment which prevents accurate application of intervention or inability to provide informed consent * end stage renal disease * uncontrolled arrhythmia's or 3rd degree av heart block * those with wounds over area of proper placement of electrodes

Keywords: sarcopenia neuromuscular electric stimulation skeletal muscles heart failure heart transplantation listing
physical activity and balance changes in operated patients because of breast cancer

Conditions: Balance and Physical Activity Deficits After Breast Surgery

Summary: balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. a significant decrease in the physical activity occurred, their balance did not deteriorate in the follow-ups. this was independent of the type of the surgery performed.


Eligibility criteria:
inclusion criteria: * patients who had breast cancer surgery exclusion criteria: * balance disorders, physical disability that will affect balance (polio sequelae) and neurological diseases with balance system and/or peripheral nervous system involvement (diabetic neuropathy and familial/genetic neuropathies, parkinson's disease, multiple sclerosis, alzheimer's disease), bone metastasis, patients who have undergone reconstructive surgery
analysis the relationship between the abdomen ct and outcomes in acute urinary stone patients

Conditions: Urinary Calculi; Emergency Service, Hospital

Summary: this is an observational study based on retrospectively collected data of ureter stone patients between 2011 and 2014. aim of study is to determine radiologic findings of non-contrast abdominal computerized tomography as predicting clinical outcomes of suspect ureter stone patients in emergency department (ed).

gennerally, non-contrast abdominal computerized tomography is a choice of diagnosis for a ureter stone patient.there was no known well of efficacy of ct for predicting the outcomes in ureter stone patient in ed. hypothesis of this study are some findings of non-contrast ct may be helpful to predict the clinical outcomes of pain severity (multidose of painkiller), admission and revisit to ed within 5 days after discharge. investigators analyzed multiple variables including age, sex, initial clinical findings, and various ct findings to assess their association with outcomes; multidose of painkiller in ed, admission at ed and revisit to ed within 5 days.

Eligibility criteria:
inclusion criteria: * ed patients * age \> 18 years * confirmed the ureter stone by abdomen or urinary ct exclusion criteria: * known a uninary congenital or acquired anomaly * combined other healthy preblem at the ed * infection, renal dysfunction et al * known the chronic disease : hypertension ,diabetes, tuberculosis, malignance et al

Keywords: computerized tomography urinary calculi patient admission pain
citriodiol® and impetigo

Conditions: Impetigo

Summary: this study aims to investigate the efficacy and safety of topical p-menthane-3,8-diol (pmd)-rich corymbia citriodora oil (citriodiol®) in children with impetigo. citriodiol® is already known to be effective as an insect repellent and is safe in its topical application. the investigators have also found in our laboratory that it is bactericidal against staphylococcus aureus, the bacteria responsible for causing impetigo. parents are always searching for a natural alternative to antibiotics (the current gold standard treatment for impetigo), and the investigators believe citriodiol® could provide this possible alternative.

the extract of lemon eucalyptus, a common plant, has since the 1970s been used in commercial insect repellent products. recently, it has been shown that lemon eucalyptus has potent anti-bacterial and anti-fungal effects that should assist in the treatment of inflammatory conditions such as impetigo. our aim is to investigate this further by investigating the safety and efficacy of this product in the treatment of impetigo. a randomised, double-blinded, three-armed pilot study, involving a total of 30 patients will be recruited from the dermatology outpatient department clinic at royal north shore hospital for this study. these patients will be between the ages of 12 months and 12 years with a clinical diagnosis of impetigo. the three treatment groups will include a 2% or 5% topical p-menthane-3,8-diol (extracted from lemon eucalyptus) and a topical mupirocin arm, which will be applied topically twice a day till resolution of symptoms. follow-up will occur weekly until resolution of symptoms, which is expected within 2 weeks. photographs, disease severity assessment and lesional swabs for culture will be taken at recruitment and as progress.

Eligibility criteria:
inclusion criteria: * age between 12 months and 12 years * dermatologist-confirmed impetigo * written informed consent provided by parents exclusion criteria: * impetigo requiring oral/systemic therapy * diagnosis of another form of staphylococcal or streptococcal disease (eg, cellulitis, erysipelas, abscess) * serious local infection (eg, cellulitis, abscess, wound infection) or systemic infection * oral or topical antibiotics * known allergy to topical insect repellents * patients receiving systemic corticosteroids, immunosuppressive agents, radiation therapy, chemotherapy within 1 month prior to entry into study * history of any clinically significant or poorly controlled cardiac, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, and/or other major disease as determined by the investigator * current enrollment in any other trial of an investigational drug within 30 days prior to study drug administration * other unspecified reasons, in the opinion of the investigator that makes the patient unsuitable for enrollment.

Keywords: p-menthane-3,8-diol oil extract topical therapy